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  • Regulatory NewsRegulatory News

    FDA Publishes New Guidance on Common Biosimilarity Questions

    A newly revised guidance document published by the US Food and Drug Administration (FDA) provides additional insight into how the agency plans to regulate biosimilar products. The latest guidance, Biosimilars -- Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act , is closely related to another guidance document released on 30 April 2015 by FDA. Both guidance documents are intended to act as question-and-...
  • Regulatory NewsRegulatory News

    After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity

    The US Food and Drug Administration (FDA) today finalized three long-sought guidance documents outlining its expectations for near-exact copies of existing biological drugs known as biosimilars. Background The trio of guidance documents had first been released in draft form for comment in February 2012, and were the first policy documents to be released by FDA after the 2010 passage of the Biologics Price Competition and Innovation Act (BPCI) under the Patien...
  • Regulatory NewsRegulatory News

    EMA Finalizes Major Guideline on Biosimilars

    The European Medicines Agency (EMA) has finalized a long-awaited guideline containing new recommendations on how to bring "similar biological medicinal products"—also known as biosimilars—to market in the EU. Background EMA first released a draft update of the guideline, Similar Biological Medicinal Products , in early May 2013. The guideline was meant to update an October 2005 guideline on biosimilarity which officials said had become outdated. The new guidelin...
  • Regulatory NewsRegulatory News

    In Major Move on Biosimilar Interchangeability, FDA Establishes New 'Purple Book'

    In a landmark move, the US Food and Drug Administration (FDA) has published its first-ever edition of the "Purple Book," a new list of licensed biological products and interchangeable biosimilars that is meant to be the biological equivalent of the pharmaceutical "Orange Book." Background FDA's Orange Book is widely used in the regulatory community (and by doctors) for identifying which drug products are substitutable for one another. The book contains all pharmaceutic...
  • Regulatory NewsRegulatory News

    FDA Receives First-Ever Biosimilar Application for Monoclonal Antibody

    South Korean biopharmaceutical manufacturer Celltrion has announced that it has filed an application for approval with the US Food and Drug Administration (FDA) for Remsima, its biosimilar version of Jannsen's Remicade (infliximab). The company's biosimilar filing is the second-ever filing of a drug through FDA's new 351(k) biosimilar pathway, and reportedly the first-ever monoclonal antibody (mAb) to seek approval through the pathway. The first biosimilar filing for ...
  • Regulatory NewsRegulatory News

    Sandoz First Company to File for Biosimilar Approval in US Under New Pathway

    Biopharmaceutical company Sandoz, a Novartis subsidiary, has announced that it has filed the first-ever biosimilar application in the US with the Food and Drug Administration (FDA) using its 351(k) pathway. Sandoz Statement The company's announcement, made 24 July 2014, says FDA has already accepted its filing for a biosimilar Neupogen (filgrastim), an FDA-approved treatment used to decrease rates of infection in patients with nonmyeloid malignancies who are already r...
  • Safety Concerns Related to Global Biosimilars Drug Development

    An initial unfortunate experience in the late 1990s served as an alert to the inherent risks of making apparently small changes to a biological product. The changes by the manufacturer to the formulation of erythropoietin, marketed as Eprex (epoetin alpha), resulted indirectly in the induction of an immune response, which manifested as a dramatic increase in the frequency of cases of pure red cell aplasia, 1 requiring some patients to have blood transfusions and dialysis...
  • FDA's Latest Biosimilars Guidance: How to Show Biosimilarity Using Pharmacological Testing

    The US Food and Drug Administration (FDA) has unveiled a new guidance document on biosimilars, this time explaining how to use clinical pharmacology data to show similarity to a reference product. Background The guidance, Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product , is one of several under development by FDA to establish a thorough biosimilar pathway. While the Patient Protection and Affordable Care Act (PPACA) ves...
  • New FDA Guidance Tries to Define When Antibody Products are 'The Same'

    A new guidance document released this week by the US Food and Drug Administration (FDA) aims to clarify the interaction of the 2012 Biologics Price Competition and Innovation Act (BPCI) and the 1983 Orphan Drug Act with respect to monoclonal antibody products. Background FDA's orphan drug regulations are intended to create market-based incentives for manufacturers of products for populations with rare diseases. Per the  Orphan Drug Act , a rare disease is defin...
  • Feature ArticlesFeature Articles

    Future FDA Biosimilars Regulation: Challenges and Possible Solutions

    Biopharmaceutical products are proteins, nucleic acids or attenuated viruses or bacteria that are produced using biotechnology and used for medical treatments or in vivo diagnostics. They are much more complex than traditional pharmaceutical products. Biopharmaceuticals currently are being used or developed for treatment of a wide range of complex diseases. Use of this highly targeted and effective group of therapeutics is restricted to patients who can bear its high co...
  • FTC Prepares to Weigh in on Biosimilar Substitution, Naming

    In recent months, regulators, legislators and advocacy groups have all been grappling with two seemingly simple questions: Should biosimilar products be given the same generic name as the original biologics they reference in their regulatory applications, and are they substitutable for the originals as well? Now US federal trade regulators say they're interested in these issues as well, observing that efforts by branded biopharmaceutical manufacturers to push for differe...
  • New EMA Guideline Establishes Framework for Biosimilars, Use of International Comparator Studies

    The European Medicines Agency (EMA) has just published a new biosimilars draft guideline for consultation that outlines the general principles that industry must take into account when developing an application to the agency. Background Generic products have long been an integral part of the pharmaceutical ecosystem. Starting in the 1980s, frameworks were set up around the world to allow for generic pharmaceutical companies to make chemical copies of existing drugs afte...